Pure Global
130293
II
current

Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmicๆ‰ซๆ็ณป็ปŸใ€ๆฟ€ๅ…‰ใ€ๅ…‰ๅญฆ็›ธๅนฒๆ–ญๅฑ‚ๆ‰ซๆใ€็œผ็ง‘

This profile provides complete Hong Kong MDACS registration information for Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic

็”ขๅ“่ณ‡่จŠ๏ผš ๆ‰ซๆ็ณป็ปŸใ€ๆฟ€ๅ…‰ใ€ๅ…‰ๅญฆ็›ธๅนฒๆ–ญๅฑ‚ๆ‰ซๆใ€็œผ็ง‘

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
18191
Product Code Detail
18191 Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Carl Zeiss Meditec Inc.
Carl Zeiss Meditec Inc.
United States
็พŽๅ›ฝ
5300 Central Parkway, Dublin, CA 94568, United States of America
5300ไธญๅคฎๅ…ฌๅ›ญๅคง้“, ้ƒฝๆŸๆž—, CA 94568, ็พŽๅ›ฝ
Authorised Representative (AR)
Carl Zeiss Far East Co., Ltd.
่”กๅธ่ฟœไธœๆœ‰้™ๅ…ฌๅธ
23320402
Regulatory Timeline
Registration Date
July 26, 2023
Expiry Date
August 30, 2028
Product Models
Cirrus HD-OCT (500, 5000)
Cirrus HD-OCT (500, 5000)